NCT07289243

Brief Summary

THIS STUDY IS A RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTATE RESECTION (TURP) AND ECHOLASER SORACTELITE-TRANSPERINEAL LASER ABLATION (TPLA) IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC OBSTRUCTION. THE PRIMARY GOAL IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jul 2024Dec 2026

Study Start

First participant enrolled

July 14, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2026

Expected
Last Updated

September 17, 2026

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

December 4, 2025

Last Update Submit

September 14, 2026

Conditions

RANDOMIZED

Outcome Measures

Primary Outcomes (1)

  • Symptomatology Improvement by International Prostate Symptoms Score (PSS-SCORE)

    After 3,6 and 12 months of follow-up International Prostate Symptom Score (IPSS) questionnaire will be administered to all participants to evaluate changes in subjective symptoms and quality of life (Lower IPSS values indicate an improvement in the symptoms reported by the patient). The IPSS ranges from 0 to 35, with scores interpreted as follows: 0-7 indicates mild symptoms, 8-19 indicates moderate symptoms, and 20-35 indicates severe symptoms

    one, three, six, twelve months after treatment

Secondary Outcomes (11)

  • Changes in the maximum urinary flow rate at Uroflowmetry (Qmax)

    Differences among preoperative status versus 6, 12 months after treatment

  • Change in Ejaculatory function as assessed by the Male Sexual Health Questionnaire - Ejaculatory function domain (MSHQ-EJD)

    Differences among preoperative status versus 3, 6, 12 months after treatmente, three, six, twelve mounth after treatment

  • Changes in Post Void Residual (PVR)

    Differences among preoperative status versus 3, 6, 12 months after treatment

  • Changes in Sexual Funtion

    Differences among preoperative status versus 3, 6, 12 months after treatment

  • Change in NIH Chronic Prostatitis Symptom Index (NIH-CPSI) score

    Differences among preoperative status versus 3, 6, 12 months after treatment

  • +6 more secondary outcomes

Study Arms (2)

TPLA

OTHER

Patients underwent TPLA tretment

Procedure: ECHOLASER-TPLA

TURP

OTHER

Patients underwent TURP tretment

Procedure: TURP

Interventions

TURPPROCEDURE

Transurethral resection of prostate, by uretrocistoscopy approach.

TURP
ECHOLASER-TPLAPROCEDURE

transperineal laser ablation of prostatic adenoma, by transrectal ultrasound guide.

Also known as: TPLA
TPLA

Eligibility Criteria

Age40 Years - 85 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lower urinary tract symptoms (IPSS \>= 8);
  • Poor efficacy after at least six months of medical therapy or intolerance to medical treatment for BPH;
  • Prostate volume: 40ml-80ml;
  • Ability to give informed consent.

You may not qualify if:

  • Previous surgery for benign prostatic hyperplasia;
  • Indwelling bladder catheter or intermittent bladder catheterization;
  • Diagnosis of bladder stones;
  • Recurrent urinary tract infections or intraprostatic abscesses;
  • Severe detrusor hypocontractility or acontractility;
  • Hydronefrosis due to urinary retention;
  • Urethral strictures or diagnosis of neurogenic bladder;
  • Diagnosis of bladder cancer;
  • Diagnosis or clinical suspicion of prostate cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UOC Urologia e Trapianti di Rene Policlinico di Bari

Bari, ITALY/Bari, 70124, Italy

RECRUITING

UOC Urologia e Trapianti di Rene Policlinico di Bari

Bari, ITALY/Bari, 70124, Italy

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Transurethral Resection of Prostate

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Marcello MZ Zingarelli, medicine and surgery

CONTACT

+393405135446marcellozingarelli86@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

July 14, 2024

Primary Completion

December 25, 2025

Study Completion (Estimated)

December 25, 2026

Last Updated

September 17, 2026

Record last verified: 2025-12

Locations

IT(2)